Exercise is Medicine: a Pilot Study
2019年12月19日 更新者：Lee Kam Pui、Chinese University of Hong Kong
Exercise is Medicine for Chronic Diseases: a Pilot Study for Future Randomized Controlled Trial
Background: Regular exercise is beneficial to patients with hypertension and/or diabetes mellitus. However, most patients cannot maintain exercise habit. The investigators had developed a program called the "exercise is medicine"(EIM), combining motivational technique, information technology use and teaching exercise techniques. Before using this intervention in a main randomized controlled trial, the investigators would like to test its feasibility and acceptability. It is hypothesized that this program is feasible and acceptable to patients.
Method: 40 patients with HT and/or DM will be recruited to attend the EIM intervention. Primary outcomes will be the rate of recruitment and rate of retention. Other clinical outcomes will be obtained before and immediately after the 12-week program.
調査の概要
研究の種類
介入
入学 (実際)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Hong Kong、香港
- Lek Yuen Clinic
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- clinic systolic BP(SBP) higher than 130mmHg (for HT class) because the Hong Kong primary care office guideline, as of Jan 2019, regarded good control of SBP to be ≤130mmHg, OR HbA1c >7% (for DM class)
- self-reported regular exercise of ≤3 times per week - this cut-off is arbitrary but people who exercise more than 3 times may have little space for improvement; and these patients will unlikely be referred to EIM when it is implemented in routine clinical practice, - who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)
Exclusion Criteria:
- patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months) are excluded because there are other evidence-proven and well-structured programmes for these patients in the Hospital Authority (HA), for instance, pulmonary rehabilitation program conducted by physiotherapy and/or occupational therapist in HA. - - acute myocardial infarction in last 6 months
- ongoing angina
- uncontrolled cardiac arrhythmia
- acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
- known aortic stenosis
- known heart failure
- known obstructive left main coronary artery stenosis
- uncontrolled ventricular rates
- complete heart block
- known hypertrophic obstructive cardiomyopathy
- mental impairment that limit co-operation
- resting blood pressure with systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg
- known anaemia with haemoglobin level less than 11gm/dL
- known uncorrected electrolyte imbalance
- known uncontrolled hyperthyroidism.
- For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months) are also excluded due to reports that vigorous exercise may increase blood pressure and led to retinal bleeding in these patients
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：EIM group
patients will go to different classes: (i) Hypertension basic exercise class (ii) Hypertension advanced exercise class (iii) diabetes basic exercise class (iv) diabetes advanced exercise class; if the patient has normal BMI AND reported some regular exercise, they will be prescribed the advanced level class.
There is no control group for this pilot study
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This is a complex intervention.
On recruitment, they will be seen by a nurse and counselled using motivational technique.
They will then undergo a 12-week class.
The exercise levels will be regularly feedback to the patients by use of mobile devices and trackers.
Peer support is formed during the 12-week class.
Resources to continue exercise will be provided to patients.
Regular monitoring of physical improvement will be feedback to patients to encourage continued exercise.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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rate of retention
時間枠：from recruitment to finish of the 12-week program
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rate of retention
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from recruitment to finish of the 12-week program
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Rate of recruitment
時間枠：from recruitment to the start of the 12-week program
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Rate of recruitment
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from recruitment to the start of the 12-week program
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Clinic blood pressure (BP)
時間枠：on recruitment and after the 12- week class
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Clinical BP will be measured 3 times and the last 2 will be averaged
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on recruitment and after the 12- week class
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HbA1c (glycosylated hemoglobin)
時間枠：on recruitment and after the 12- week class
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for DM patients only
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on recruitment and after the 12- week class
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Godin-Shephard Laiesure-Time Physical Activity Questoinnaire
時間枠：on recruitment and after the 12- week class
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a validated questionnaire to detect change in exercise level
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on recruitment and after the 12- week class
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body mass index (BMI)
時間枠：on recruitment and after the 12- week class
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the weight and height of the patients will be measured
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on recruitment and after the 12- week class
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body fat percentage
時間枠：on recruitment and after the 12- week class
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body fat percentage
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on recruitment and after the 12- week class
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lipid level
時間枠：on recruitment and after the 12- week class
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this will include low-density lipoprotein, high-density lipoprotein, and total lipoprotein
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on recruitment and after the 12- week class
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9-item patient health questionnaire
時間枠：on recruitment and after the 12- week class
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a validated questionnaire to detect depressive symptoms
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on recruitment and after the 12- week class
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Generalized anxiety disorder-7
時間枠：on recruitment and after the 12- week class
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a validated questionnaire to detect anxiety symptoms
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on recruitment and after the 12- week class
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EQ-5D-5L
時間枠：on recruitment and after the 12- week class
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a validated questionnaire to measure quality of life
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on recruitment and after the 12- week class
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年5月21日
一次修了 (実際)
2019年9月1日
研究の完了 (実際)
2019年12月1日
試験登録日
最初に提出
2019年4月16日
QC基準を満たした最初の提出物
2019年4月18日
最初の投稿 (実際)
2019年4月19日
学習記録の更新
投稿された最後の更新 (実際)
2019年12月20日
QC基準を満たした最後の更新が送信されました
2019年12月19日
最終確認日
2019年12月1日
詳しくは
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